NCT04847674终止2 期
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety, Efficacy and Pharmacodynamics of TEV 53275 Administered Subcutaneously in Adult Patients With Persistent Eosinophilic Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 82
- 主要终点
- Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.
详细描述
The planned study duration is approximately 16 months.
The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is an adult female or male ≥18 years of age. Note: Age requirements are as specified or allowed by local regulations.
- •The participant has a diagnosis of asthma for at least 6 months and has been stable without exacerbation or change in medications for at least 1 month..
- •Current Asthma Therapy: The participant has been maintained for at least 1 month on stable doses of:
- •medium or high dose inhaled corticosteroids (ICS)±another controller.
- •any fixed dose combination ICS (low, medium, or high) with long-acting beta agonist (LABA)±another controller.
- •Women of non-childbearing potential, or congenitally sterile, or 1-year postmenopausal. Women of childbearing potential must have a negative β-human chorionic gonadotropin (β-HCG) test result and practice a highly effective method of birth control prior to investigational medicinal product (IMP) administration and 30 weeks after the dose of IMP.
- •The participant, as judged by the investigator, is able to continue their current asthma maintenance medications throughout the study.
- •NOTE- Additional criteria apply, please contact the investigator for more information.
排除标准
- •Life threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated hypercapnea, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- •The participant has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period. Note: Participants who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the run-in period may rescreen 2 weeks after symptoms resolve and undergo coronavirus disease 2019 (COVID-19) testing.
- •Participants with a confirmed infection with COVID-19 within 3 months prior to the screening visit.
- •The participant has an eosinophilic condition including hypereosinophilic syndrome, eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis (EGPA [Churg Strauss syndrome]), or allergic bronchopulmonary aspergillosis.
- •The participant has an active helminthic or parasitic infection currently or within the last 6 months.
- •The participant has a history of malignancy other than fully resected basal cell carcinoma of the skin.
- •The participant has any clinically significant, uncontrolled medical or psychiatric condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the participant's safety.
- •The participant has known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies (Ab), or human immunodeficiency virus (HIV) Types 1 or 2 Ab (according to 4th generation serology testing).
- •The participant is a pregnant or lactating woman, or plans to become pregnant during the study.
- •The participant has previously participated in a study with TEV-
- •The participant has participated in another study of an IMP (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device).
- •The participant has been treated with a monoclonal antibody used to treat asthma or other inflammatory conditions within the washout period (5 half-lives), has demonstrated hypersensitivity or anaphylaxis to a monoclonal antibody (Appendix G),or is currently using or has used a systemic immunosuppressive medication within the last 6 months. NOTE: Prior depemokimab exposure is prohibited without exception.
- •The participant has a history of chronic alcohol or drug abuse within the previous 2 years.
- •The participant currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes [20 cigarettes]/day for 1 year), OR the participant used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco), OR the participant has smoked marijuana within 1 month, OR the participant has a history of "vaping" tobacco, marijuana, or any other substance within 24 months.
- •Vulnerable participants (eg, people kept in detention).
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
TEV-53275 Dose A
Experimental
干预措施: TEV-53275 Dose A (Drug)
TEV-53275 Dose B
Experimental
干预措施: TEV-53275 Dose B (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 12
时间窗: Baseline, Week 12
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Least square (LS) mean and standard error (SE) were calculated using a mixed model for repeated measures (MMRM).
次要结局
- Number of Participants With Well-controlled Asthma Status (Yes Versus No) at Weeks 12 and 16(Weeks 12 and 16)
- Number of Participants Who Achieved Clinic-based FEV1 ≥80% Predicted at Weeks 12 and 16(Weeks 12 and 16)
- Change From Baseline in the Weekly Average of Daily Morning Trough (Pre-Rescue Bronchodilator) FEV1 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16(Baseline, up to Week 12, up to Week 16)
- Change From Baseline in FEF25-75 Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16(Baseline, up to Week 12, up to Week 16)
- Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Weeks 12 and 16(Baseline, Week 12, Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline up to Week 30)
- Number of Participants Who Received at Least 1 Concomitant Asthma Medication(Baseline up to Week 30)
- Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value(Baseline up to Week 30)
- Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value(Baseline up to Week 30)
- Change From Baseline in Weekly Average of Rescue Medication Use Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16(Baseline, up to Week 12, up to Week 16)
- Change From Baseline in Clinic-based Standardized Baseline-adjusted Morning Trough (Pre-bronchodilator) FEV1 at Week 16(Baseline, Week 16)
- Change From Baseline in Asthma Control Questionnaire (ACQ-6) Score at Weeks 12 and 16(Baseline, Week 12, Week 16)
- Number of Participants With Injection Site Reactions(Baseline up to Week 30)
- Number of Participants Who Did Not Complete the Study Due to AEs(Baseline up to Week 30)
- Time to First Clinical Asthma Exacerbation (CAE)(Baseline up to Week 16)
- Number of Participants Who Achieved FEV1:FVC Ratio ≥0.80 at Weeks 12 and 16(Weeks 12 and 16)
- Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study(Baseline up to Week 30)
- Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value(Baseline up to Week 30)
- Change From Baseline in Weekly Percentage of Asthma Control Days (No Symptoms and No Rescue Medication Use) Over 12 Weeks From Week 1 Through 12 and Over 16 Weeks From Week 1 Through 16(Baseline, up to Week 12, up to Week 16)
- Change From Baseline in Asthma Control Test (ACT) Score at Weeks 12 and 16(Baseline, Week 12, Week 16)
- Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities(Baseline up to Week 30)
- Number of Participants Who Achieved Forced Expiratory Flow at 25% to 75% of Forced Expiratory Volume (FVC) (FEF25-75) ≥70% Predicted at Weeks 12 and 16(Weeks 12 and 16)
- Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram Values(Baseline up to Week 30)
研究者
研究点 (82)
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